My key client is currently under a massive expansion and is growing their current presence in Ireland. They are looking for an experienced within their brand new Biologics site.
This Japanese owned pharmaceutical company based in Dublin and is named in the top 15 pharmaceutical companies in the world.
The Qualified Person (Biologics) is a key member of the Quality Assurance team associated with sterile manufacture of an Advanced Therapeutic Medicinal Product (ATMP) at the companies Dublin site
In particular, the Qualified Person (Biologics) will assume the role of Qualified Person for the release of ATMP in accordance with EU Directive 2001/83/EC.
In accordance with business needs, the Qualified Person (Biologics) may assume responsibilities in any work area of the Quality Department.
As with all site personnel, the Qualified Person (Biologics) is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the Dublin site.
The responsibilities of the Qualified Person (Biologics) include the following:
- Management of batch disposition and material status control activities associated with Advanced Therapeutic Medicinal Product acting as a Qualified Person.
- Management of review of Batch Manufacturing Records (BMRs).
- Primary Degree in a scientific discipline
- Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.
- Minimum of 5 years' experience in the pharmaceutical industry in a Quality role.
- Experience of sterile manufacture is essential.
- Experience of biologics manufacture is desirable.
Not sure yet? No CV ready? Please contact me for more information.
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Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales